MAUDE Adverse Event Report: AESCULAP AG CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM; CRANIAL FIXATION

Model Number	FM921T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap ag that a cranioplate 1.5 scr.Mag.Cross l:4mm (part # fm921t) was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the screw was broken.The complaint device was not returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information - d9 investigation results: visual investigation: investigation was carried out visually and microscopically.We made a microscopic investigation of all screws.All screws show damage.These are pronounced to different degrees on all screws.They are in detail: damaged threads, damaged phillips screw heads, broken screw tips and deformations.The fracture surface of the broken off tips show the typical signs of a screw that was torn off by excessive torque.The phillips heads show significant wear and deformation.Without further knowledge about the circumstances we suspect that the surgeon made some handling errors during implantation.The instruction for use points out to consider some points during handling and implantation.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.There is one similar complaint against the same lot number.The review of risk assessment revealed that the overall risk level (severity 5(10) x probability of occurrence 7(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM
• Common Device Name: CRANIAL FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12924482
• Report Number: 9610612-2021-00768
• Device Sequence Number: 12186758
• Product Code: JEY
• UDI-Device Identifier: 04038653463671
• UDI-Public: 4038653463671
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FM921T
• Device Catalogue Number: FM921T
• Device Lot Number: 52683232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown